Medical Device Manufacturer · US , Minneapolis , MN

Sulzer Spine-Tech - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1999
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sulzer Spine-Tech Orthopedic ✕
7 devices
1-7 of 7
Cleared Sep 24, 2002
CADENCE SPINAL FIXATION SYSTEM
K022374 · KWP
Orthopedic · 64d
Cleared May 02, 2002
RPX TITANIUM CEMNT RESTRICTOR
K020344 · JDK
Orthopedic · 90d
Cleared Feb 15, 2002
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
K020196 · MNH
Orthopedic · 24d
Cleared Sep 28, 2001
DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM
K012173 · KWP
Orthopedic · 78d
Cleared Aug 22, 2001
MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM
K012305 · KWQ
Orthopedic · 30d
Cleared Nov 16, 1999
SILHOUETTE SPINAL FIXATION SYSTEM
K993067 · KWP
Orthopedic · 64d
Cleared Oct 01, 1999
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
K992276 · MNI
Orthopedic · 86d
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